Post-Launch Product R&D Expenses definition
Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4 clinical trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance), in each case that are (a) specifically attributable to a ZIOPHARM Product in the countries of the Territory where such ZIOPHARM Product has been launched and (b) approved by both Parties in writing.
Post-Launch Product R&D Expenses shall include certain research and development costs incurred by a Party in relation to a Licensed Product after the first commercial launch and shall exclude administrative expenses and costs that are included within Costs of Goods or Development Costs. Such post-launch research and development costs shall include the following expenses only if such expenses are directly attributable to a Licensed Product:
Post-Launch Product R&D Expenses shall have the meaning set forth in Exhibit A.
Examples of Post-Launch Product R&D Expenses in a sentence
Development Expenses shall further include costs of Phase IV Trials and Post-Launch Product R&D Expenses.
All Phase IIIb Costs and Phase IV Costs shall be Post-Launch Product R&D Expenses, which are taken into account in the calculation of Product Profit, except for those Phase IIIb Costs incurred with respect to a Phase IIIb Trial that the Parties mutually agree to include within the scope of Development pursuant to Section 3.2(e).
More Definitions of Post-Launch Product R&D Expenses
Post-Launch Product R&D Expenses means certain research and development costs incurred by a Party in relation to a Collaboration Product for the Shared Territory in the Field after the First Commercial Sale in the Shared Territory of such Collaboration Product and required to obtain or maintain a Regulatory Approval in the Shared Territory. Such post-launch research and development costs shall include Phase IV Clinical Trials and ongoing medical affairs.
Post-Launch Product R&D Expenses means the costs of Phase IV -------------------------------- Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support necessary for product maintenance) which are specifically attributable to a Collaboration Product in the Co-Promotion Territory where such Collaboration Product has been launched, excluding costs that are included within Costs of Goods Sold or Development Expenses. Post- Launch Product R&D Expenses shall be calculated in the manner set forth in Exhibit A.
Post-Launch Product R&D Expenses means the reasonable costs, excluding administrative expenses and costs that are included within Costs of Goods Sold, of Phase 4
Post-Launch Product R&D Expenses means the costs of Phase IIIB Clinical ---------------------------------- Trials and Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product safety and efficacy) and medical affairs (including regulatory support safety and surveillance necessary for product maintenance) which are specifically attributable to a Collaboration Product in the Profit/Loss Sharing Territory where such Collaboration Product has been launched, excluding costs that are included within Costs of Goods Sold or Development Expenses and any costs reasonably associated with maintaining Regulatory Approval of Collaboration Compounds and Products. Post-Launch Product R&D Expenses shall be calculated in the manner set forth in Exhibit A. Notwithstanding the foregoing, with respect to Phase IIIB Clinical Trials for Bromocriptine specifically identified in Exhibit E, the costs of such trials shall not be a Post-Launch Product R&D Expense, but shall instead be treated as a Development Expense for the purposes of this Agreement, but ORTHO may elect for its internal purposes to treat such expenses as commercialization expenses.
Post-Launch Product R&D Expenses means the following research and development costs and expenses, including the cost of FTEs, incurred or accrued (as applicable in accordance with Article 1 of this Financial Appendix) by a Party in direct relation to a Collaboration Product after the first commercial launch of a Collaboration Product: Phase 4 Trials, ongoing Collaboration Product support, ongoing medical affairs (meaning pharmacoeconomic studies, outcomes studies and extramural studies), preclinical research (including without limitation investigation of additional therapeutic uses), and fees and expenses of outside counsel in respect of regulatory affairs unrelated to obtaining Regulatory Approvals.
Post-Launch Product R&D Expenses means the costs of Phase IV Clinical Trials and ongoing product support (including manufacturing and quality assurance technical support, and laboratory and clinical efforts directed toward the further understanding of product